Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anisodamine hydrobromide combined with heparin.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
Overview
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Detailed description
Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically infected patients requiring vasopressor use. The critically infected patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.
Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group.
Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.
Interventions
- Drug Anisodamine hydrobromide combined with heparin
The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.
Primary outcome measures
- 28-day mortality [Time frame: Every patients' survival time will be observed on day 28 after admission.]
Secondary outcome measures (1)
- Lactate clearance rate [Time frame: The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.]
Eligibility criteria
Inclusion criteria
- Age greater than 18 years;
- Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ;
- Patient or their legal representative consents to treatment and signs an informed consent form.
Exclusion criteria
- Patients expected to die within 24 hours after enrollment;
- Contraindications to low molecular weight heparin and scopolamine butylbromide drugs;
- Patients with thrombotic diseases requiring treatment with low molecular weight heparin;
- Patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.;
- Pregnant and lactating women;
- Patients participating in other clinical trials.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT05634057 · Z211100002921061